Introducing Permallon® Avant Alumina Matrix Composite

 

 

From CoorsTek Bioceramics, a leading manufacturer of technical ceramic components for the orthopaedic implant device industry, comes Permallon® Avant.

Permallon® Avant is a leading-edge alumina matrix composite developed specifically for use as a ceramic bearing surface for total hip arthroplasty. The microstructure of Permallon™ Avant is engineered to incorporate advanced toughening mechanisms to improve mechanical integrity. Proven to provide excellent wear performance for femoral heads, Permallon® Avant offers favorable mechanical performance as compared to the leading ceramic femoral head material.

The chemical composition and physical makeup of the material is also designed to be biocompatible and stable, and to provide excellent wear performance.

CoorsTek Bioceramics offers standard specifications as well as custom design and manufacturing capabilities for Permallon® Avant orthopaedic hip implant components.

Material Benefits

• BiocompatibleSuperior axial burst strength
• No metallic ion generation at bearing surface
• High hardness for optimum wear resistance
• Hydrothermally stable

Increased Burst Strength

Permallon™ Avant femoral head samples (28-12/14 L tested with a titanium taper) passed fatigue testing and are well in excess of the FDA Guidance for post fatigue burst. The axial burst strength of the Permallon™ Avant ceramic femoral head compares favorably to the leading industry standard material for ceramic femoral heads.¹

The Permallon™ Avant ceramic femoral heads were subjected to loading that exceeds physiological conditions. In addition, these components are well in excess of the industry standards for strength.

 

Custom Manufacturing

CoorsTek Bioceramics works in partnership with our customers to create custom femoral heads with an expanded ranges of sizes and design options.

CoorsTek Bioceramics manufactures state-of-the-art technical ceramics for the medical device industry. Since 2005, CoorsTek Bioceramics has manufactured over six million products from implant grade materials. With a focus on total joint replacements including ceramic bearing components for Total Hip Arthroplasty, CoorsTek Bioceramics components can also be found in other surgical implant devices for neurological, cardiological, spinal, and radiological applications.

Founded in 1910, CoorsTek is a leading global manufacturer of technical ceramics for the medical, semiconductor, aerospace, automotive and other industries. With over 400 proprietary ceramic material formulations, vertically integrated systems, and unparalleled process capabilities, CoorsTek partners with its customers to make the world measurably better.

 

Customer Regulatory Certifications and Clearances

Devices incorporating CoorsTek Bioceramics products are registered by our customers in locations worldwide. Check for regulatory approval in your area.

CoorsTek Bioceramics maintains comprehensive technical files containing technical data and laboratory test results on the biological, mechanical, and tribological properties of the Permallon® Avant ceramic materials and products for total hip arthroplasty.  These files are used to support the regulatory process for device submissions incorporating Permallon® Avant ceramic femoral heads.

Quality Systems and Certifications

CoorsTek Bioceramics offers best in class quality standards and testing procedures. Permallon® Avant ceramics are manufactured in an ISO 13485 certified facility that is FDA CFR 820 compliant. Permallon® Avant ceramic femoral heads undergo strict quality control throughout the manufacturing process, from the preparation of the ceramic material through final testing.

Stability and Longevity

CoorsTek is a leading global supplier of technical ceramics. Family owned and operated and in continuous operation since 1910, CoorsTek provides high-performance components to virtually every industry. CoorsTek Bioceramics has supplied over six million critical implantable ceramic components since 2005.

¹Haftel, Jon, Chief Engineer, CoorsTek Bioceramics. 2022. "Technical Overview of Permallon® Avant
Alumina Matrix Composite Ceramic Material Manufactured by CoorsTek Bioceramics": pp. 10-11.
Tested by Static Compression of 28-12/14 L (+3.5mm) Femoral Head with Titanium Taper